The purpose of this Notice is to modify the language of RFA-RM-09-019 with regard to research subject advocacy in the Regulatory Knowledge and Support section and with regard to literature cited in the Format of the Application.

In RFA-RM-09-019 Regulatory Knowledge and Support language currently states:

Each CTSA should name an individual independent of the IRB or compliance officer to act as a sounding board for potential research participants, serve as an advocate for research participants, and work with investigators, trainees and research teams to ensure that the highest priority is given for human subject protections.

This is now modified to read:

Each CTSA should provide research participant protections through research subject advocacy functions that should be independent from the IRB function, to be complementary and integrative with existing entities at the institution and work with investigators, trainees and research teams to promote and facilitate safe and ethical conduct of human research.

In RFA-RM-09-019 Format of the Application language currently reads:

G. Literature cited

This is now modified to read:

G. Literature cited

(a) Bibliography and References Cited – Provide a bibliography of any references cited in the Research Plan. Each reference must include names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Include only bibliographic citations. Follow scholarly practices in providing citations for source materials relied upon in preparing any section of the application.

The references should be limited the relevant and current literature. While there is not a page limitation, it is important to be concise and select only those literature references pertinent to the proposed research.

(b) Progress Report Publication List – For Renewal applications list the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively.

All other aspects of the FOA remain unchanged.

Inquiries

We encourage your inquiries concerning this Notice and welcome the opportunity to answer questions from potential applicants: